FDA-Device2020-08-12Class II

Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167

Mako Surgical Corporation
Hazard

Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.

Sold states
TX, MN, CA, RI, FL, NY, AZ, TN
Affected count
12 units
Manufactured in
2555 Davie Rd Ste 110, Davie, FL, United States
Products
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2745-2020

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